Influenze of Approach in Reversed Shoulder Prosthesis

Hospital del Mar

Status: Completed

Conditions: Rotator Cuff Arthropathy; Outcomes Assessments, Patients

Treatments: Procedure: Reverse Shoulder Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04405947

2015/7913/I

Details and patient eligibility

About

To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.

Full description

Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
• Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
• No previous surgeries of the affected shoulder
• Acceptance by the patient to participate in the study

Exclusion criteria

• Fractures> 2 weeks of evolution
• Previous surgeries on the affected shoulder
• Not signing the informed consent
• Cognitive impairment
• Institutionalization of the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

deltopectoral

Other group

Description:

deltopectoral surgical approach

Treatment:

Procedure: Reverse Shoulder Arthroplasty

antero-superior

Other group

Description:

antero-superior approach

Treatment:

Procedure: Reverse Shoulder Arthroplasty